Valencell has developed a mobile sensor technology - called Healthset(R) technology - for monitoring vital signs and physical activity via a wireless audio earbud. This highly miniaturized sensor technology can be integrated into audio headsets, headphones, hearing aids, and ear jewelry for seamless mobile monitoring of energy expenditure. Valencell's long-term goal is to augment Healthset technology to provide a seamless mobile energy balance monitoring solution, integrated within a single, wearable, wireless, highly miniaturized, audio earpiece. This mobile solution will satisfy several imminent public needs: 1) the clinical need for an all-in-one wearable energy balance monitor for disease prevention and health management, 2) the academic need for a portable, automated physiological data collection tool, and 3) the consumer demand for an engaging, mobile fitness assessment platform. The specific goal of this Phase II program is to clinically validate a scalable and seamless energy expenditure monitoring platform. This work will involve implementing improvements to Healthset sensor technology as well as optimizing the statistical models relating sensor metrics to energy expenditure. Furthermore, a mobile solution for integrating energy expenditure monitoring (via Healthset technology) with energy intake monitoring (via 3rd party web applications) will be implemented and validated. This mobile solution will connect the user's wireless Healthset earbud and mobile handset with 3rd party mobile web applications (such as food and weight diaries), and the combined data will be processed to provide a meaningful and useful energy balance metric. This mobile solution will allow 3rd party applications to provide important energy intake data to the Healthset platform, including food diaries and wireless scales, as well as emerging sensor technologies currently under development by universities, government labs, and industry. In this NIH Phase II program, Valencell will: 1) fabricate and qualify Phase II Healthset prototypes for mobile energy expenditure monitoring, 2) optimize statistical models for estimating total (TEE) and resting (REE) energy expenditure, 3) implement a seamless mobile solution integrating energy expenditure with energy intake, and 4) validate the mobile solution in a field environment. This Phase II program will demonstrate a seamless energy balance monitoring platform that is suitable for transitioning to large-scale commercialization in a Phase III program. PUBLIC HEALTH RELEVANCE: Modifiable health risk factors such as high stress, poor diet, and a sedentary lifestyle account for 25% of all medical expenses and millions of deaths per year worldwide. Seamless mobile energy balance monitoring can empower individuals to live healthier lives, saving trillions in medical expenses. The technology proposed in this Phase II program will help make healthy lifestyles easier, more effective, and more affordable.